US · guidance
CMS SOM App. H, Tag V341
ANSI/AAMI RD47:2002/A1:2003 Requirements as Adopted by Reference 42 CFR §
494.50(b)(1)
11.4.1.6 Chemical germicide concentration
[For] reprocessing systems in which each batch of germicide is manually prepared, each
batch of germicide shall be tested before use to verify the proper concentration of the
Page 148 of 420
germicide. This requirement does not apply in cases in which each dialyzer is tested for
concentration before setup.
When the germicide is diluted on-line, its concentration in the hemodialyzer immediately
after reprocessing should be checked at least monthly for each reprocessing system.
When the germicide is partially or fully diluted by the user, the solution [shall] be
thoroughly mixed [before use].
Interpretive Guidance 494.50(b)(1)
The system in use must include verification of germicide concentration in the dialyzers after
reprocessing.
If the germicide is diluted by the user (batch), the germicide manufacturer's instructions for
dilution must be followed, and the solution must be thoroughly mixed before use. If each dialyzer
is tested for germicide concentration prior to rinsing, it is not necessary to test the germicide
concentration before use of the batch.
If the germicide is diluted on-line, the concentration in a dialyzer from each reprocessing system
must be checked immediately after reprocessing at least monthly.
History
Rev.
Provenance
- Source
- cms.gov
- Retrieved
- 2026-07-22
- Edition
- som-2026-07-22
- Content hash
71e3a93148b656ae5ccbbaa160cae663e3d9bf639e466af360251c9f14506366
The link goes to the issuing authority’s own document — the one we read to produce this record. Where a source publishes whole titles rather than sections, your browser may need a moment to jump to the provision.
Unofficial copy of government-published law, reproduced from official sources with full provenance. Not an official publication; verify against official sources before relying on it in a filing. Records in the 'guidance' corpus, and only that corpus, are sub-regulatory (interpretive guidelines, survey procedures) and are not binding law. Validity bounds follow each jurisdiction's declared temporalBasis.